User Manual: Vacuklav 24 B+ Vacuklav 30 B+
User Manual: Vacuklav 24 B+ Vacuklav 30 B+
User Manual: Vacuklav 24 B+ Vacuklav 30 B+
Vacuklav® 24 B+
Vacuklav® 30 B+
Steam sterilizer
from software version 5.17
EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality man-
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.
Contents
Contents
1 General guidelines ............................................................................................................................................................... 5
Symbols used....................................................................................................................................................................... 5
Formatting rules ................................................................................................................................................................... 5
2 Safety..................................................................................................................................................................................... 6
7 Sterilization ......................................................................................................................................................................... 24
Important information regarding routine operation ............................................................................................................. 24
Selecting the program ........................................................................................................................................................ 25
Additional program options ................................................................................................................................................ 26
Starting the program .......................................................................................................................................................... 27
Program run ....................................................................................................................................................................... 27
Program end ...................................................................................................................................................................... 28
Manual program abort........................................................................................................................................................ 28
Removing the sterilized equipment .................................................................................................................................... 30
Storing sterile instruments.................................................................................................................................................. 30
8 Logging ............................................................................................................................................................................... 31
Batch documentation ......................................................................................................................................................... 31
Output media...................................................................................................................................................................... 32
Outputting logs immediately and automatically.................................................................................................................. 34
Subsequent log output ....................................................................................................................................................... 35
Contents
10 Maintenance...................................................................................................................................................................... 42
Servicing intervals .............................................................................................................................................................. 42
Cleaning ............................................................................................................................................................................. 42
Avoiding staining ................................................................................................................................................................ 43
Replacing the door seal ..................................................................................................................................................... 43
Replacing or sterilizing the sterile filter............................................................................................................................... 44
Cleaning the filter in the chamber ...................................................................................................................................... 46
Maintenance....................................................................................................................................................................... 46
12 Malfunctions ..................................................................................................................................................................... 48
General events................................................................................................................................................................... 48
Warnings ............................................................................................................................................................................ 49
Malfunction messages ....................................................................................................................................................... 52
Opening the door in an emergency following a power outage ........................................................................................... 57
Replacing the device fuses ................................................................................................................................................ 58
Glossary ................................................................................................................................................................................. 61
1 General guidelines
1 General guidelines
Read this user manual carefully before commissioning the device. The user manual includes important
safety information. The functionality and value-retention of this device depends on the care accorded to it.
Store this user manual carefully and in close proximity to your device. It represents a component of the
product.
Should the user manual no longer be legible, damaged or lost, obtain a new copy from MELAG. State the
device type and your address in an e-mail.
The device type is specified on the type plate on the rear of the device.
Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to life-
threatening injuries.
Draws your attention to a situation, which if not avoided, could result in damage to the
instruments, the practice fittings or the device.
Draws your attention to important information.
Formatting rules
Example Explanation
see Chapter 2 Reference to another text section within this document.
Universal- Words or phrases appearing on the display of the device are marked as display text.
Program
5
2 Safety
2 Safety
When operating the device, comply with the following safety instructions as well as those
contained in subsequent chapters. Use the device only for the purpose specified in these
instructions. Failure to comply with the safety instructions can result in injury and/or damage to
the device.
Qualified personnel
n As with the preceding instrument decontamination, the sterilization of instruments and textiles using
this steam sterilizer may only be carried out by competent personnel.
Carrying the steam sterilizer
n The device should always be carried by two people.
n Use the correct carrying straps to carry the device.
Set-up, installation and commissioning
n Check the device for any damage suffered during transport after unpacking.
n The device should only be set-up, installed and commissioned by MELAG authorized technicians.
n The connections for electrical provision and water supply and discharge must be set-up by trained
personnel.
n Using the optional electronic leak detector (water stop) minimizes the risk of water damage.
n The device is not suitable for operation in explosive atmospheres.
n Install and operate the device in a frost-free environment.
n The device is conceived for use outside the patient area. The device should be located a minimum of
1.5 m radius away from the treatment area.
n The documentation media (computer, CF card reader etc.) must be placed in such a way that they
cannot come into contact with liquids.
n Observe all the information contained in the technical manual during commissioning.
Power cable and power plug
n Comply with all legal requirements and locally-specified connection conditions.
n Never operate the device if the plug or power cable are damaged.
n The power cable or plug should only be replaced by authorized technicians.
n Never damage or alter the power plug or cable.
n Never unplug by pulling on the power cable. Always take a grip on the plug.
n Ensure that the power cable does not become jammed in.
n Never lead the cable along a source of heat.
n Never fix the power cable with sharp objects.
Spring loaded safety valve
n The free movement of the valve rod must be guaranteed. For example, the spring safety valve must
not be taped or blocked. Install the device in such a way that the proper functioning of the spring
loaded safety valve is guaranteed.
Decontamination and sterilization
n Follow the manufacturer’s instructions of your textile articles and instruments regarding their decon-
tamination and sterilization.
n Comply with the relevant standards and directives applicable to the decontamination and sterilization
of textiles and instruments in Germany e.g. from the RKI and DGSV.
n Only ever use packaging material and systems which have been cleared by their manufacturer for
steam sterilization.
6
2 Safety
Program abort
n Please observe that depending on the time of the program abort, opening the door following a pro-
gram abort can lead to hot steam leaving the chamber.
n Depending on the time of the program abort, it is possible that the load is unsterile. Observe the clear
instructions shown on the display of the steam sterilizer. If necessary, sterilize the affected objects
after rewrapping.
Removing the sterilized equipment
n Never use force to open the door.
n Use a tray jack to remove the tray. Never touch the sterilized items, the chamber or the door with
unprotected hands. The components are hot.
n Check the packaging on the sterilized equipment for damage when removing it from the steam
sterilizer. Should the packaging be damaged, re-pack the sterilization material and re-sterilize it.
Transport and storage
n Store and transport the device in a frost-free environment.
n The device should always be carried by two people.
n Use suitable carrying straps to carry the device.
Maintenance
n Maintenance should only be performed by authorized technicians.
n Maintain the specified servicing intervals.
n Only original MELAG spare parts may be used.
Malfunctions
n Should the device issue the same malfunction message repeatedly, turn off the device and if
necessary, inform your stockist.
n The device may only be serviced by authorized technicians.
Notification requirement in the event of serious accidents in the European Economic Area
n Please note that all serious accidents which occur in connection with the medical product (e.g. death
or serious deterioration in the state of health of a patient) which were presumably caused by the
product, must be reported to the manufacturer (MELAG) and the relevant authority of the member
state, in which the user and/or patient resides.
7
3 Performance specifications
3 Performance specifications
Intended use
This steam sterilizer is designed for application in a medical context, e.g. general practitioners and dental
practices. According to DIN EN 13060, this steam sterilizer is considered as a steam sterilizer with type B
cycles. As an universal steam sterilizer, it is suited to highly-demanding sterilization tasks. It can be used
for a range of tasks such as the sterilization of large quantities of instruments with narrow lumen and trans-
mission instruments - both wrapped or unwrapped - and of textiles.
WARNING
Any attempt to sterilize liquids can result in a delay in boiling. This can result in burns
and damage to the device.
n Never use this device to sterilize fluids. It is not licensed for the sterilization of fluids.
Sterilization procedure
The steam sterilizer sterilizes on the basis of the fractionated vacuum procedure. This guarantees the
complete and effective wetting/penetration of the sterilization material with saturated steam.
The steam sterilizer uses a separate steam generator to generate sterilizing steam. Steam is generated
upon program start and led into the sterilization chamber. This establishes a pre-defined pressure and
temperature. The sterilization chamber is protected against overheating. You can sterilize large quantities
of instruments or textiles directly one after each other, thereby achieving excellent drying results.
Automatic preheating
If preheating is activated, the cold chamber is heated up to the preheating temperature of the particular
program before program start, or this temperature is held between two program runs. This reduces pro-
gram times and reduces the accretion of condensation, thus improving drying results.
8
3 Performance specifications
Safety equipment
Internal process monitoring
A process evaluation system is integrated in the electronics of the steam sterilizer. It compares the process
parameters (such as temperature, time and pressure) during a program run. It monitors the parameters in
terms of their threshold values during control and regulation and guarantees safe and successful
sterilization. A monitoring system checks the device components of the steam sterilizer for their
functionality and their plausible interaction. If one or more parameters exceeds pre-determined threshold
values, the steam sterilizer issues warnings or malfunction messages and if necessary, aborts the pro-
gram. In the case of a program abort, follow the instructions on the display.
The steam sterilizer uses an electronic parameter control. This enables the steam sterilizer to optimize the
total operating time of a program in dependence on the load.
Door mechanism
The steam sterilizer constantly checks pressure and temperature in the sterilization chamber and prevents
the door from being opened when over-pressure has built up in the chamber.
9
3 Performance specifications
Program sequences
Regular sterilization program
A program runs in three phases: air removal, sterilization and drying phase. After program start, you can
follow the program run on the display. It shows the chamber temperature and pressure as well as the time
until the end of sterilization / drying.
Vacuum test
The vacuum test measures the leakage rate. No real sterilization is performed. The test is performed with
a cold, dry and unloaded device.
10
3 Performance specifications
Overview of programs
MAIN menu
Program run
P
Abort before
Quick-Program B S drying
134°C START
-------- Program running --------
S Cancel program?
P 'Stop’ key
Gentle-Program S
121°C
Program
P aborted
Abort during
Pressure release
Prion-Program drying 1.52 bar 112°C
134°C wrapped 20'
Stop / End
P Immediate removal Cancel programm 0.02 bar 88°C
press 'Stop' 'Stop’ key
Acknowledge
Bowie & Dick-Test S with '-’ key
134°C 2.2 bar 3.5'
Quick-Program B Drying
run successfully aborted
-
P
11
3 Performance specifications
Functions of the SETUP menu
12
hh:mm:ss
0.00 bar 89°C Initial state
S P S P S P S P S P S P S P
Scope of delivery
Please check the scope of delivery before setting up and connecting the device.
13
4 Description of the device
6
7
12 11
14
4 Description of the device
13 Chamber
13 14 Door locking pin
15 Chamber sealing face
14
16 Cap for emergency activation of
the vacuum pump
15
17 2x Device fuse
18 Motor protection switch reset
16 button
19 Serial data and printer connection
(RS232)1)
20 Door seal
21 20 19 18 17 21 Round blank
Fig. 3: View of the interior
The user manual includes important safety information. Failure to comply with these
instructions can result in injury and material damage.
Please read this user manual carefully before commissioning the device.
In affixing this CE mark, the manufacturer declares that this medical product fulfils the
basic requirements of the Medical device directive. The four-digit number confirms that
this is monitored by an approved certification agency.
1)
hidden behind white cover
15
4 Description of the device
In affixing this CE mark, the manufacturer declares that this product fulfils the basic
requirements of the Pressure equipment directive. The four-digit number confirms that
this is monitored by an approved certification agency.
With the adjacent label, the device manufacturer declares that the medical product
corresponds to the basic requirements of the European standard EN 1717 - Protecting
Drinking Water from Contamination.
The device may not be disposed as domestic waste. The vendor is responsible for
appropriate disposal of the device - it must be delivered to the vendor to be disposed of.
MELAG devices are synonymous for long-term quality. When you eventually need to
decommission your MELAG device, we offer a special disposal service. Simply contact
your stockist.
Operating panel
The operating panel consists of a two-row alphanumerical LC display and four membrane keys.
1 2 3
14:27:12
0,02bar 25 °C
4 5 6
1 2-row LC display
for display of the program status and parameters
2 Time (h:min:s)
3 Chamber pressure (bar) and (steam) temperature (°C)
4 Function keys '-' and '+'
for the selection, setting and display of special functions: printing, date / time, preheating, total
batches, conductivity, acknowledge malfunction, '+' key for unlocking the door
5 Program selection key 'P'
for selecting the sterilization program / test program and selection / setting of the options
(submenus) of the special functions
6 Start – Stop key 'S'
for starting programs, aborting programs / drying and controlling the special functions
Initial state
The display switches to the initial state after every activation of the device. This displays the current time,
the chamber pressure in bar and the (steam) temperature in °C.
16
4 Description of the device
Load mounts
Detailed information regarding the various mounts, their combinability with various load holders and their
application can be found in the separate document “Usage instructions for mounts”.
Mount A Plus
The mount (A Plus) is standard and can
accommodate either five trays or three MELAstore
Boxes 100 when turned 90˚.
Mount D
The mount (D) can accommodate two tall
sterilization containers (e.g. MELAstore Box 200) or
four trays (when turned 90°).
17
5 First steps
5 First steps
PLEASE NOTE
Comply with the specifications of the technical manual during set-up and installation.
This contains all building-side requirements.
NOTICE
Danger of algae development
n To prevent the development of algae, never expose the storage container to sunlight.
PLEASE NOTE
Should you wish to use a water treatment unit from another manufacturer, please consult
MELAG.
18
5 First steps
PLEASE NOTE
All accessories must be removed from the chamber directly after the steam sterilizer has
been switched on for the first time and before initial commissioning.
After device activation, a heating up time of approx. 5 min (Vacuklav 24 B+) or approx. 3 min
(Vacuklav 30 B+) is required depending on the device type. A program will be started only after the target
temperature has been reached.
PLEASE NOTE
When switching off the device via the power switch, wait three seconds before switching
it back on.
Function
Date / time
19
5 First steps
9. After ending the settings, press the 'S' key to leave the menu.
Ê The display will show the message Function: Date / Time.
10. Repeated pressing of the 'S' key enables you to leave the menu and the display returns to its initial
state.
20
6 Loading the steam sterilizer
NOTICE
Only ever operate the steam sterilizer with a sterile filter inserted.
Decontaminating textiles
WARNING
The incorrect decontamination of textiles, e.g. a textile package can prevent steam
penetration and/or produce poor drying results. The textiles could not be sterilized.
This could endanger the health of patient and practice team.
Comply with the following when decontaminating textiles and putting the textiles in sterilization containers:
u Comply with both the manufacturer's instructions of the textiles regarding decontamination and
sterilization as well as the relevant standards and directives e.g. from the RKI and DGSV.
u Arrange the folds in the textiles parallel to each other.
u Stack textiles vertically wherever possible and not too closely together in the sterilization container.
This enables the development of flow channels.
u If textile packages do not remain together, wrap the textiles in sterilization paper.
u Only ever sterilize dry textiles.
u The textiles may not be permitted to come into direct contact with the sterilization chamber; otherwise
they will become saturated with condensate.
WARNING
The incorrect decontamination of instruments could result in any dirt residue being
loosened by the steam pressure during sterilization.
The use of unsuitable care agents e.g. water repellent agents or oils impermeable to
steam could result in unsterile instruments. This represents a danger to the health of
both patients and yourself.
NOTICE
The presence of residual disinfection and cleaning fluids results in corrosion.
This could result in increased maintenance requirements and a restriction of the steam
sterilizer function.
Unwrapped sterile material loses its sterility on contact with ambient air. If you intend to store your instru-
ments sterilely, wrap them in suitable packaging before sterilization.
21
6 Loading the steam sterilizer
Packaging
Only ever use packaging materials and systems (sterile barrier systems) which comply with the standard
DIN EN ISO 11607-1. The correct use of suitable packaging is important in achieving successful steriliza-
tion results. You can use re-usable rigid packaging systems or soft packaging such as transparent sterili-
zation packaging, paper bags, sterilization paper, textiles or fibre web.
CAUTION
The use of unsuitable sterilization containers results in insufficient steam penetration
and even failure of the sterilization. This can also prevent condensate drain-off.
Consequences are poor drying results. This can result in unsterile instruments and thus
endanger the health of patient and practice team.
CAUTION
Incorrect stacking of the sterilization containers can result in the dripping condensate
being unable to drain off to the chamber floor. This can saturate sterilization material
directly underneath it.
Consequences are poor drying results. Ultimately, this can result in unsterile
instruments and thus endanger the health of patient and practice team.
n Do not cover the perforations when stacking the sterilization containers.
22
6 Loading the steam sterilizer
u Wherever possible, please ensure that sterilization containers are only stacked on top of those of
identical size, so that the condensate can run down their sides.
u Ensure that the perforations are not covered when stacking the containers.
Tip: MELAG sterilization containers fulfil the requirements of DIN EN 868-8 for successful sterilization and
drying. They have a perforated lid and base and are fitted with disposable paper filters.
Multiple wrapping
The steam sterilizer works with a fractionated pre-vacuum procedure. This permits the use of multiple
wrapping.
Mixed loads
Please observe the following when sterilizing mixed loads:
u Always place textiles at the top.
u Place the sterilization containers at the bottom.
u Place unwrapped instruments at the bottom.
u Place the heaviest loads at the bottom.
u Place transparent sterilization packaging and paper bags at the top - except in combination with
textiles. In this case, place them at the bottom.
Load versions
Example:
23
7 Sterilization
7 Sterilization
PLEASE NOTE
The results of the tests must be documented.
2)
in accordance with the current recommendations from the Robert Koch Institute
24
7 Sterilization
3)
without drying, with a full load and dependent on the load and set-up conditions (e.g. cooling water temperature, if a
fixed water connection is present, and mains voltage)
25
7 Sterilization
PLEASE NOTE
The steam sterilizer must remain continually activated for the automatic preheating.
MELAG recommends activating the automatic preheating function.
Function:
autom. preheating
Additional drying
selected
26
7 Sterilization
NOTICE
Unsupervised operation of electrical devices, including this steam sterilizer at the
operator’s risk. MELAG accepts no liability what so ever for any damage resulting from
unsupervised operation.
After having selected a program via the program selection key 'P', the display will show both the selected
program and sterilization temperature as well as whether the program is suitable for wrapped or un-
wrapped sterilization material.
Universal-Program
134 °C wrapped
PLEASE NOTE
If the Quick-Program S has been started, the warning Attention: Unwrapped
instruments only appears on the display.
If the load contains exclusively unwrapped instruments, press the 'S' key again to
confirm and to start the program.
Program run
After starting the program, you can follow the program run in the display. It shows the chamber
temperature and pressure as well as the time until the end of sterilization / the drying time which has
passed.
1. Fractionation
-0.085 bar 22 °C
Sterilization phase
The display enables you to see whether the sterilization phase has already been completed successfully.
The time left in the sterilization phase is shown in the display in alternation with the pressure and
temperature.
Sterilization
2 min, 12 s
Drying phase
The regular drying time for the Quick-Program S amounts to approx. 5 min. For the Quick-Program B ap-
prox. 10 min and for all other programs 20 min. The display will show the corresponding message during
the drying phase.
Vacuum drying
since 2' -0.12 bar 60 °C
27
7 Sterilization
The steam sterilizer provides excellent drying of the sterilization material. If difficult-to-dry items require
better drying, you can undertake the following steps to improve drying:
u Load the steam sterilizer properly. Stand e.g. the transparent and paper sterilization packaging
upright. Comply with the specifications of section Loading the steam sterilizer [} page 22]. Use the
optional package holder if necessary.
u Activate the Additional drying function. Comply with the specifications of section Additional
drying [} page 26].
Program end
When the program has been completed successfully, the display shows:
Universal-Program
run successfully
Working in the SETUP menu Function under Last batch number, if immediate output after program
end is activated, the log of the completed program will be outputted to the activated output medium after
opening the door, see Logging [} page 31].
WARNING
Hot steam can be released from the device when opening the door after a program abort.
This could result in burns.
n Use a tray lifter to remove the tray.
n Never touch the sterilized equipment, the chamber or the door with bare hands. The
components are hot.
NOTICE
Aborting a running program by switching off the power switch can result in the egress of
hot steam from the sterile filter and will cause the soiling of the sterile filter.
n Never abort a program by switching off at the mains.
WARNING
Danger of infection from early program abort
Aborting a program before the drying phase begins means that the load is unsterile. This
endangers the health of your patients and practice team.
n If necessary, repack the load and repeat the sterilization for the sterilization material
affected.
28
7 Sterilization
PLEASE NOTE
The security query will be displayed for approx. five seconds. If the 'S' key is not pressed
again, the program will continue with the usual program run.
Depending on the time of the abort, pressure will be released or the device will be ventilated. A corres-
ponding display text appears on the display.
After pressure release or ventilation, you will be asked to acknowledge the program abort.
The display will alternate between Stop / End and Acknowledge with '-' key.
3. Press the '-' key.
Ê The display will alternate between Unlock door with '+' key and the program previously
selected.
4. You can open the door after pressing the '+' key.
Ê The log will contain: Program stopped / Load not sterile!
Immediate removal
press 'Stop'
PLEASE NOTE
The security query will be displayed for approx. five seconds. If the 'S' key is not pressed
repeatedly, the program will continue with the usual program run.
2. Confirm the following security query Immediate removal 'Stop' by pressing the 'S' key again.
Ê The display confirms the abort with Drying stopped.
After ventilation of the chamber, the display will show: Universal-Program run successfully in
alternation with:
If a printer or other output medium is connected to the steam sterilizer, and Immediate output is set
to YES, the warning Drying stopped is recorded on the log.
29
7 Sterilization
CAUTION
Danger of burns from hot metal surfaces
n Allow the device to cool sufficiently before opening.
n Do not touch any hot metal parts.
CAUTION
Unsterile instruments resulting from damaged or burst packaging. This endangers the
health of your patients and practice team.
n Should the packaging be damaged or have burst, re-pack the sterilization material and re-
sterilize it.
If you remove the sterilized equipment from the device directly after the end of the program, it is possible
that the instruments can be partially damp. According to the red broschure of the Arbeitskreis für Instru-
mentenaufbereitung (AKI), the tolerable residual moisture is - in practice - a few drops of water capable of
evaporating within 15 min, but actual pools of water are not acceptable.
Comply with the following specifications when removing the sterilized equipment:
u Never use force to open the door. This could damage the device or result in the emission of hot
steam.
u Use a tray lifter to remove the tray.
u Never touch the sterilized equipment, the device interior or the inside of the the door with unprotected
hands. The components are hot.
u Check the packaging on the sterilized equipment for damage when removing it from the device.
Should the packaging be damaged, re-pack the sterilization material and re-sterilize it.
30
8 Logging
8 Logging
Batch documentation
The batch documentation serves as proof of the successful conclusion of the program and represents an
obligatory part of quality assurance (MPBetreibV). The device internal log memory saves such data as the
program type, batch and process parameters of all the programs completed.
To obtain the batch documentation, you can output the internal log memory and transfer its data to various
output media. This can be performed immediately at the end of every program or at a later point, such as
at the end of the day.
You can also arrange for the batch number to be displayed. To do so:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will
show Function: Last batch number.
2. Press the 'P' key to display the current daily batch number.
3. To return to the initial state, press the 'S' key twice.
Total batch
22
3. Press the 'P' key to display the current total batches counter.
4. To return to the initial state, press the 'S' key twice.
31
8 Logging
Output media
You are able to output and archive the logs of the completed programs on the following output media:
▪ MELAflash CF card printer on the CF card
▪ Computer, e.g. with MELAtrace/MELAview software (optionally with MELAnet Box)
▪ MELAprint 42/44 log printer
In its delivery state, an option for log output is not set on the steam sterilizer.
PLEASE NOTE
Further information about the log printer (e.g. the duration of the readability of the log
printouts) is specified in the appendant user manual.
ü The computer is either fitted with a serial interface or a USB serial adapter is connected.
ü The documentation software MELAview/MELAtrace is installed on the computer.
PLEASE NOTE
The MELAnet Box is required for integration in the (practice) network.
PLEASE NOTE
If the computer is constantly connected to the steam sterilizer, you can insert the serial
cable in the cable duct (pos. 3) fold in the metal strap and replace the cover.
1 2 3 4
Fig. 4: Connection on the steam sterilizer
32
8 Logging
Output medium
Computer
6. Press the 'P' key to confirm. The display switches back into the Log output – Output medium
menu.
7. Press the 'S' key to return to the SETUP menu Function: Log output.
8. After repeated pressing of the 'S' key, the display returns to its initial state.
PLEASE NOTE
Graphic logs cab only be displayed with the MELAtrace / MELAview (from MELAview 3)
documentation software.
Each text log (e.g. .PRO, .STR, .STB etc.) must be linked with the text editor to enable the operating sys-
tem of your computer to open them automatically with a text editor. The meanings of the endings are out-
lined in the section Subsequent log output [} page 35]. The following examples show how you can link
the Windows 10 editor with a specific text log.
1. Working in Windows Explorer, double click on the
log file.
33
8 Logging
Ê You can then open files with this ending via a double-click in Windows Editor.
Alternatively, you can open all text logs with the documentation software MELAtrace / MELAview (from
MELAview 3).
ü Working in SETUP menu Function: Log output, immediate output is set to YES.
ü At least one output medium must be selected (computer, MELAprint 42/44 log printer).
ü The activated output medium must be connected and initialized.
Immediate output
YES
34
8 Logging
PLEASE NOTE
If immediate output is unable to output a log, for example, because the output medium
activated is not connected, a warning will appear. MELAG recommends using the
immediate log output function.
For log output immediately after program end, comply with the following:
u In SETUP menu Function: Log output MELAnet+graphic data must be selected as the output
medium.
u The computer or another medium must be connected and initialized.
Last cycle
output: 25
35
8 Logging
3. Navigate using the '+' or '-' keys until the display shows:
Output
stored cycles
4. Press the 'P' key in order to start the output of the selected program. Once the issue has been
performed, the display will show: Output.
Ê If output has been performed, the display will again show: Output stored cycles.
5. Press the 'S' key to leave the submenu without outputting the log.
PLEASE NOTE
An abort during log output on the log printer is only possible during deactivation of the
device using the power switch or by interrupting the power supply to the printer.
When switching off the device via the power switch, wait three seconds before switching
it back on.
6. Press the 'S' key to leave the menu. The display will show SETUP menu Function: Log output.
7. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
initial state.
Allocated: 26
Free: 14
Delete
all cycles
36
8 Logging
Log header
The header of the program log comprises the general basic information regarding the program run. This
includes e.g. date, the selected program, the daily batch number and the steam sterilizer type.
Summary
The summary states whether the program has been completed successfully. The values of the sterilization
time required, the sterilization temperature and the pressure (including the maximum deviation) are also
displayed.
37
8 Logging
------------------------------------------ ----------------------------------------------------------
MELAG Vacuklav 24-B Steam sterilizer type
------------------------------------------ ----------------------------------------------------------
Program : Universal program
134°C Packaged
Program started
Date : 27.03.2015 Current date
Time of day : 08:36:39 (Start) Time upon program start
Batch number: 10 Daily batch number
SN : 201524-B1150 Serial number
----------------------------------------------------------
Preheating 81.2 °C
AIN6: Conductivity 7 µS/ cm Preheating temperature
Feed water conductivity
------------------------------------------ ----------------------------------------------------------
SUMMARY - Control notification
Program properly executed!
Median sterilization temperature with max. deviations
Temperature : 135.8 +0.4 /-0.3 °C Median sterilization pressure with max. deviations
Pressure : 2.17 +0.03/-0.03 bar Sterilization time maintained
Sterilizate time: 5 min 30 s Time upon program end
Time of day : 09:19:06 (End)
==========================================
----------------------------------------------------------
26 201501150 5.15 5.05 Information with total batch counter, factory number and
device software number / version no.
Fig. 5: Example for a text log of a successfully completed program.
38
9 Function tests
9 Function tests
Batch-related tests
Helix test body system MELAcontrol / MELAcontrol PRO
The Helix test body system MELAcontrol is an indicator and batch control system fulfilling the requirements
of DIN EN 867-5. It consists of a test body, the Helix and an indicator strip.
When sterilizing category “critical B“ instruments, you should add the MELAcontrol / MELAcontrol PRO test
body to every sterilization cycle as a batch control.
Regardless of this, you can perform a steam penetration test in the Universal-Program at any time using
MELAcontrol / MELAcontrol PRO.
Intended use of the Helix test body can result in the colouration of the plastic surface. This colouration
exercises no influence on the functionality of the Helix test body.
Vacuum test
The test detects leaks in the steam sterilizer. This determines the leakage rate at the same time.
Perform a vacuum test in the following circumstances:
▪ Once a week in routine operation
▪ During commissioning
▪ Following longer operating pauses
▪ In the case of a corresponding malfunction (e.g. in the vacuum system)
Perform the vacuum test with the steam sterilizer in a cold and dry state as follows:
1. Switch on the device at the power switch. The display switches to its initial state.
2. Press the 'P' key until the display shows Vacuum test.
3. Close the door.
4. Press the 'S' key to start the vacuum test.
Ê The evacuation pressure and the equilibration time or measuring time are shown on the display. The
chamber is ventilated after the end of the measuring time. Then the message will be shown on the
display with an indication of the leakage rate. Should the leakage rate be too high i. e over 1.3 mbar, a
corresponding message will be issued on the display.
39
9 Function tests
The current daily batch number and Acknow. with '+' key is displayed. You can open the door after
pressing the '+' key.
PLEASE NOTE
If a log printer or another output medium is connected and the setting Immediate
output YES is set, a log printout will be issued at the same time.
PLEASE NOTE
If a log printer or another output medium is connected and the setting Immediate
output YES is set, a log printout will be issued at the same time.
PLEASE NOTE
Treatment indicator strips often exhibit differing intensities in the colour change
indicating a different length of storage of the manufacturer batches or other influences.
Of crucial importance for evaluating the Bowie & Dick test is not the strength of contrast
in the colour change on the test sheet, but its even nature.
If the treatment strips/treatment indicator sheet indicates an equal distribution of colour
change, the venting of the sterilization chamber is without fault.
If the treatment indicator strips or the treatment indicator sheets are uncoloured or
exhibit less colour in the centre of the star in comparison to the end, venting was
insufficient. In this case, contact the authorized customer services / stockist technician.
AIN6: Conductivity
15 µS/cm
} To do so, hold the '-' key depressed until the display shows Conductivity.
Ê The conductivity is displayed in µS/cm.
Ê As soon as you have released the '-' key, the display returns to its previous state (e.g. initial state).
40
9 Function tests
Ê The conductivity display disappears and the preheating temperature in the chamber will be
displayed.
41
10 Maintenance
10 Maintenance
Servicing intervals
Interval Measure Device components
Daily Check for soiling, deposits or Chamber inc. door seal and chamber
damage sealing face, door lock, mount for the load
After 24 months or Maintenance By the authorized customer services
1000 cycles working in accordance with the
maintenance instructions
As required Cleaning the surfaces Housing parts
Cleaning
NOTICE
Inappropriately performed cleaning can lead to the scratching of and damage to surfaces
and the development of leaks in sealing surfaces.
This also favours the development of soiling deposits and corrosion in the sterilization
chamber.
n Comply with all information regarding cleaning of the part affected.
Housing parts
Where necessary, clean the housing parts with a neutral fluid cleaner or spirit.
42
10 Maintenance
Interval
Upon every refill Check the storage container for soiling. Clean any soiling before refilling
the storage container.
At least once a month Depending on the light, ambient temperature and consumption, clean the
external water storage container to prevent the development of germs
and algae. To do so, empty the container and clean it with approx. 3 l of
warm tap water with a neutral cleaning agent and a suitable brush. Rinse
with a large quantity of tap water at least twice. Always rinse the storage
container with a litre of feed water after completing the cleaning.
Avoiding staining
Only proper cleaning of the instruments prior to sterilization enables you to avoid residue from being
released from the load under steam pressure during sterilization. Loosened dirt residue can clog the filter,
nozzles and valves of the steam sterilizer and deposit themselves on the instruments and chamber as
deposits and stains.
All steam-conducting parts of the steam sterilizer consist of non-rusting material. This rules out the
possibility of stain or rust development being caused by the steam sterilizer. Any rust which develops is
always extraneous rust.
Incorrect instrument decontamination can result in the accretion of rust even on stainless steel instruments
of leading manufacturers. Often, an instrument which drops rust can suffice to cause the development of
rust on another instrument or in the steam sterilizer. Remove extraneous rust from the instruments using a
chlorine-free stainless steel cleaning agent (see the Cleaning [} page 42] section) or send the damaged in-
struments to the manufacturer for treatment.
The extent of stain accretion on the instruments is also dependant on the feed water used for steam
generation.
43
10 Maintenance
PLEASE NOTE
Make sure that the broad seal face faces the chamber. The door can only be shut
correctly and the chamber sealed, if the door seal sits correctly in the groove.
NOTICE
Only ever operate the steam sterilizer with a sterile filter inserted.
44
10 Maintenance
45
10 Maintenance
Maintenance
NOTICE
Continuing operation beyond the maintenance interval can result in malfunctions in the
device.
n Maintenance should only be performed by trained and authorized service technicians or
stockist technicians.
n Maintain the specified servicing intervals.
Regular maintenance is vital to ensure reliable operation and value retention of the steam sterilizer. All
function and safety-relevant components and electrical units must be checked during maintenance and
replaced where necessary. Maintenance is performed in accordance with the maintenance instructions
pertinent to this steam sterilizer.
Arrange for regular maintenance in 24 months intervals or after 1000 program cycles. The steam sterilizer
will issue a maintenance message at the relevant time.
46
11 Pause times
11 Pause times
Frequency of sterilization
Pause times between individual programs are not necessary. After the end/abort of the drying time and
removal of the sterilized equipment, you can load the steam sterilizer again and start a new program.
Operating pauses
Depending on the duration of the operating pauses, the following measures must be maintained:
Decommissioning
When decommissioning the steam sterilizer for a long pause (e.g. due to holiday or planned transport),
proceed as follows:
1. Switch off the steam sterilizer at the power switch.
2. Disconnect the power plug from the socket.
3. Clean the storage container if present.
4. Close the water inflow if you are using a water treatment unit.
PLEASE NOTE
Comply with the specifications of the technical manual when transporting. The manual
contains detailed instructions.
47
12 Malfunctions
12 Malfunctions
Warnings
Warnings are not malfunction messages. They help to ensure malfunction-free operation and to recognize
undesirable situations. Comply with these warnings early in order to avoid malfunctions.
Malfunction messages
Malfunction messages are issued on the display with an event number. This number serves identification
purposes. Malfunction messages are issued when it is not possible to ensure safe operation or safety of
sterilization. These can appear on the display shortly after activating the steam sterilizer or during a pro-
gram run.
If a malfunction occurs during a program run, the program will be aborted.
WARNING
Danger of infection from early program abort
Aborting a program before the drying phase begins means that the load is unsterile. This
endangers the health of your patients and practice team.
n If necessary, repack the load and repeat the sterilization for the sterilization material
affected.
General events
Incident Possible causes What you can do
Empty display Insufficient power supply. Check the power plug for its correct
position in the socket.
Check the mains voltage at the socket.
If necessary, replace the device fuses on
the lower front the steam sterilizer, see
Replacing the device fuses [} page 58].
Door cannot be The door seal sticks to the seal face. 1. Switch on the steam sterilizer.
opened 2. Press the '+' key to open the door and
pull strongly on the door in order to
open it.
Feed water The steam sterilizer has been Comply with the load quantities, see
consumption too high loaded incorrectly. Loading the steam sterilizer [} page 21].
The steam sterilizer has not been Check that the steam sterilizer is set up
set-up correctly. correctly. If necessary, increase the slope
of the device feet by unscrewing them by
max. two revolutions.
Condensate reflux is prevented. Remove any instruments, filter paper or
other objects which have fallen onto the
chamber floor.
48
12 Malfunctions
Warnings
Incident Possible causes What you can do
Notice: no feed water/ When using the external water storage container:
check the feed water There is too little or no water in the Check the cooling filling level and refill if
inflow storage container. necessary.
The inflow hose is kinked. Check for the kink-free installation of the
inflow hose.
The suction left is too high (max. Check the position of the suction fittings on
suction lift 1.5 m from the floor of the the floor of the storage container.
external water storage container to
the suction fittings of the steam
sterilizer).
When using a MELAG water treatment unit:
The suction filter of the external Clean the suction filter.
water storage container is blocked.
The warning will be displayed after a MELAdem 40/53/53 C:
program start. The installed flow Check the water treatment unit and open
monitor does not close. the inflow to the system if necessary. Upon
repeated incidence, contact an authorized
customer services / stockist technician.
MELAdem 47:
Check the water treatment unit and if
necessary, open the inflow to the system.
Perform a new start with an empty
pressure storage after approx. one hour.
Upon repeated incidence, contact an
authorized customer services / stockist
technician.
PLEASE NOTE: This message can be
issued following commissioning /
recommissioning, as the pipe system is still
empty. Repeat the start.
49
12 Malfunctions
50
12 Malfunctions
51
12 Malfunctions
Malfunction messages
Incident Possible causes What you can do
F02 The steam sterilizer is overloaded. Comply with the maximum permissible load
quantities, see Loading the steam sterilizer
[} page 21].
The incline to the steam sterilizer is too Check the incline of the steam sterilizer to the rear.
flat. Complete condensate drainage from the sterilization
chamber is only possible with a sufficient rearwards
incline.
Starting with the device in a level position, the fore
device feet are to be extended to the following
extent: Vacuklav 24 B+: min. five rotations,
Vacuklav 30 B+: three rotations.
The mains voltage is too low, poor Check the building-side socket / test the steam
building voltage supply (e.g. undersized sterilizer using a different socket or circuit.
installation, defective socket, multiple
devices on a single socket/fuse) so that
the steam generator cannot heat up.
F04 The chamber filter “Condensate return” Screw out the “Condensate return” filter (in the rear
is blocked. area of the chamber floor) and check whether it is
soiled/blocked. Clean the filter if necessary, see
Cleaning the filter in the chamber [} page 46].
The wastewater outflow is impeded. Check the installation of the wastewater hose. This
must be installed without kinking or sagging and at a
constant decline.
Check whether the building siphon is blocked.
PLEASE NOTE: If multiple devices are operated
simultaneously, we recommend the installation of an
additional siphon.
F06 The sterile filter is blocked. 1. Check whether the sterile filter suction aperture
(centre aperture) on the rear panel of the steam
sterilizer is blocked. If yes, replace it with a new
sterile filter, see Replacing or sterilizing the ster-
ile filter [} page 44].
2. If nothing can be recognized, remove the sterile
filter on the rear panel of the steam sterilizer and
perform a program run without a load. If the pro-
gram has been ended successfully, the sterile
filter is blocked. In this case, replace the sterile
filter.
F08 The internal device time monitoring is Check the building-side socket / test the steam
defective. sterilizer using a different socket or circuit or connect
to a mains filter. Upon repeated incidence, arrange
for an electrician to check the electricity supply for
electromagnetic disruption.
F09 The door has not been closed correctly Close the door correctly and start the program again.
upon program start. PLEASE NOTE: To shut the door correctly, press it
against the steam sterilizer lightly and slide the
locking slider downwards to its fullest extent.
An attempt was made to open the door Do not attempt to open the door during a program
during a program run. run.
F10 The overheat control of the steam Allow the steam sterilizer to cool for approx. 2 min
generator has triggered. and then restart the program.
PLEASE NOTE: This notification can be issued if a
program is started immediately after a malfunction or
a program abort.
52
12 Malfunctions
53
12 Malfunctions
54
12 Malfunctions
55
12 Malfunctions
56
12 Malfunctions
WARNING
The steam sterilizer must be completely pressure free.
Failure to observe this provision can result in scalding / injury.
n No steam may be permitted to leave from between the sterile filter and the rear panel of the
steam sterilizer.
n The slide seal grip must be easy to actuate.
n It must be possible to push the door approx. 2 mm to the rear with light pressure.
n It is imperative that you allow the steam sterilizer to cool. Metal parts such as the door and
chamber can be hot.
Should it not be possible to open the door e.g. following a power outage, taking into account the safety
information specified above, proceed as follows:
1. Switch off the steam sterilizer at the mains and
remove the plug from the socket.
57
12 Malfunctions
58
13 Technical data
13 Technical data
4)
In Prion-Program with porous full load.
59
14 Accessories and spare parts
You can obtain the specified articles and an overview of further accessories from your stockist.
60
Glossary
Glossary
Air leakage Delay in boiling
An air leakage is a location through which air can This refers to the phenomenon that it is possible
pass in and out without this being desired. Verifica- under certain circumstances to heat a fluid beyond
tion of the leakage serves to prove that the volume its boiling point without them boiling. This repre-
of air ingress in the chamber during the vacuum sents an unstable state; even low-level agitation
phase does not exceed a value which would pre- can produce a large bubble within the shortest
vent steam penetration of the sterilizer load and period, which expands explosively.
that the air leakage does not cause the possible
contamination of the sterilizer load during the dry- Demineralized water
ing phase. Water without the minerals usually found in normal
spring or tap water; is produced through ion ex-
AKI change of normal tap water. It is used here as feed
Abbr.: working group instrument preparation ( "Ar- water.
beitskreis Instrumentenaufbereitung")
DGSV
Authorized technician Abbr.: Deutsche Gesellschaft für Sterilgutver-
The term “authorized technician” refers to an em- sorgung (German Society German Society for
ployee of a customer service provider or stockist Sterile Supply). The DSGV training centres are
who has been trained and authorized by MELAG specified in DIN 58946, part 6 as "Requirements of
to perform maintenance and installation work on personnel".
MELAG devices. Only they may carry out this
work. DIN 58946-7
Standard – sterilization - steam steam sterilizers -
Batch part 7: Building requirements and requirements
The batch is the composition of items which has placed on the operating agents and the operation
been subject to the same decontamination of steam sterilizers in the health-care branch
procedure.
DIN 58953
BGV A1 Standard – sterilization, sterile equipment supply
BGV is the abbreviation for Berufsgenossenschaft-
liche Vorschriften (regulations from a professional DIN EN 13060
association). A1 stands for principles of prevention Standard – small steam sterilizers
61
Glossary
62
Glossary
Sterilized equipment
Also referred to as a batch: a load which has
already been sterilized, i.e. is sterile
Vacuum
In common parlance, an area devoid of all material
In the technical sense: volumes with a reduced gas
pressure (at least air pressure)
63
BA_24B+_30B+_10054_10050_EN.pdf | Rev. 15 - 20/2651 | Modification date: 2020-11-18
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Email: [email protected]
Web: www.melag.com
Original instructions
Your stockist